When any trial-related duties are transferred to a CRO, what must be specified in writing?

• A. The CRO Must Assume All Regulatory Responsibilities
• B. The Transfer Is Informal and Not Documented
• C. All Trial-Related Duties and Functions Transferred to a CRO Should Be Specified in Writing
• D. The Sponsor Remains Silent on Duties

Answer: (C)

When any trial-related duties are handed to a CRO, everything being delegated needs to be described in writing. This written specification lays out the exact duties and functions transferred, who will perform them, the extent of their authority, and how oversight will be conducted. The reason this is essential is that it creates a clear, auditable record of responsibilities, ensures sponsor accountability for the trial’s quality and integrity, and aligns with GCP expectations that delegation is formal, supervised, and compliant with protocol and regulations. A written agreement also helps prevent gaps or miscommunications by precisely outlining what the CRO will do, what processes they’ll follow, and how performance, reporting, monitoring, and escalation will occur. In short, documenting the full scope of transferred duties in writing is the standard practice to maintain proper governance and regulatory compliance.